The Clinical Research Coordinator II works independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. May plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Develops and maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements.
2. Works with PIs and Research Nurses to ensure the completion and maintenance of consent forms, case report forms, and source documents to ensure that research is being conducted according to GCP, FDA, HSPC, HIPAA and other agency guidelines.
3. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
4. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
5. If qualified as a Medical Assistant, may assist with clinical procedures, phlebotomy, providing related patient care when required, including vital signs, EKGs, and specimen collection and testing as directed by physician investigators. If phlebotomy certified, may assist with phlebotomy services as directed by physician investigators.
6. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and research participant safety.
7. Notifies direct supervisor about concerns regarding data quality and study conduct.
8. Facilitates research participant screening, recruitment and scheduling, initiating research participant records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.’s research staff, pharmaceutical company monitors, etc.
9. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care. Provides assistance with research participant research billing and reconciliation.
10. Maintains system for monitoring and maintenance of research participant data records.
11. May provide technical support for the preparation of grant proposals, publications, presentations and special projects.
12. Participates in weekly research staff meetings.
13. Protects rights and research data of research volunteers, including medical records, data, etc. Obtain necessary consent forms, or HIPAA information forms as needed, in research process.
14. Coordinates training and education of other personnel.
15. Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
16. Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
17. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
18. May identify new research opportunities and present to investigators.
19. Participates in required training and education programs.
20. Performs other related duties as assigned or required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Develops and maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements.
2. Works with PIs and Research Nurses to ensure the completion and maintenance of consent forms, case report forms, and source documents to ensure that research is being conducted according to GCP, FDA, HSPC, HIPAA and other agency guidelines.
3. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
4. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
5. If qualified as a Medical Assistant, may assist with clinical procedures, phlebotomy, providing related patient care when required, including vital signs, EKGs, and specimen collection and testing as directed by physician investigators. If phlebotomy certified, may assist with phlebotomy services as directed by physician investigators.
6. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and research participant safety.
7. Notifies direct supervisor about concerns regarding data quality and study conduct.
8. Facilitates research participant screening, recruitment and scheduling, initiating research participant records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.’s research staff, pharmaceutical company monitors, etc.
9. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care. Provides assistance with research participant research billing and reconciliation.
10. Maintains system for monitoring and maintenance of research participant data records.
11. May provide technical support for the preparation of grant proposals, publications, presentations and special projects.
12. Participates in weekly research staff meetings.
13. Protects rights and research data of research volunteers, including medical records, data, etc. Obtain necessary consent forms, or HIPAA information forms as needed, in research process.
14. Coordinates training and education of other personnel.
15. Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
16. Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
17. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
18. May identify new research opportunities and present to investigators.
19. Participates in required training and education programs.
20. Performs other related duties as assigned or required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires a strong understanding of Good Clinical Practice in Clinical Trials. In addition, strong interpersonal skills are needed to work effectively with research participants, their physicians and/or families; pharmaceutical company representative and other project personnel. Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently accurate. Require the ability to multi-task and manage time efficiently.
The position also requires the following:
EDUCATION and/or EXPERIENCE:
Bachelor’s degree required, preferably in a health science or related area. Minimum of four (4) years experience in clinical research coordination or CRC certification (ACRP/SoCRA), or related experience. Experience working in cardiology or transplantation disciplines preferred. Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred. Graduate of an accredited Medical Assistant school, certified by a medical assistant certifying organization approved by the California Board of Medicine, documented medical assistant equivalent military experience or training, or documented physician attestation of training and proficiency that meets the requirements of the California Medical Board preferred. Phlebotomy certification preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires a strong understanding of Good Clinical Practice in Clinical Trials. In addition, strong interpersonal skills are needed to work effectively with research participants, their physicians and/or families; pharmaceutical company representative and other project personnel. Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently accurate. Require the ability to multi-task and manage time efficiently.
The position also requires the following:
- High energy with a focus on meeting deadlines;
- Able to prioritize and maintain progress on multiple scientific projects;
- Supportive of finding creative solutions to complex scientific and business challenges;
- Customer focused in a way that ensures desired outcomes are achieved;
- Collegial and highly participative at all levels;
- Focused on providing cutting edge technology that solves real business challenges and ultimately produces better treatment alternatives for patients.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree required, preferably in a health science or related area. Minimum of four (4) years experience in clinical research coordination or CRC certification (ACRP/SoCRA), or related experience. Experience working in cardiology or transplantation disciplines preferred. Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred. Graduate of an accredited Medical Assistant school, certified by a medical assistant certifying organization approved by the California Board of Medicine, documented medical assistant equivalent military experience or training, or documented physician attestation of training and proficiency that meets the requirements of the California Medical Board preferred. Phlebotomy certification preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
